A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management

NCT05842733 | Unknown Phase 2 DMC

• 1 other identifier: Oral SDE+AAP-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety, efficacy, and pharmacokinetics of oral SafeTynadol, Naldebain and Naldebain combine with SafeTynadol in the treatment of moderate to severe pain following knee replacement.

Conditions

Pain, Postoperative

Keywords

SafeTynadol; Naldebain

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of visual analogue scale

  Pain assessment calculated as the area under the curve (AUC) of visual analogue scale (VAS, 0-100 mm) pain intensity scores through 70 ± 2 hours after the first dose.

  0 hour - 70 hours after first dose

Secondary Outcomes (6)

• The first time using any one kind of rescue medication

  Day 1 - Day 4

• Consumption of rescued parecoxib

  Day 1 - Day 4

• Brief Pain Inventory short form (BPIsf)

  Day 2 - Day 4

• The evaluation of adverse events

  Day 1 - Day 6

• Patient satisfaction

  Day 4

Study Arms (3)

Naldebain

ACTIVE COMPARATOR

Oral Placebo A 650 mg + Naldebain 37.5 mg (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.

Drug: Naldebain

SafeTynadol

ACTIVE COMPARATOR

Oral SafeTynadol 650 mg + Placebo B (0.5 mL oil solution) +Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.

Drug: SafeTynadol

Naldebain + SafeTynadol

ACTIVE COMPARATOR

Oral Naldebain 37.5 mg (0.5 mL oil solution) + SafeTynadol 650 mg + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 25 hours after the first dose.

Drug: Naldebain + SafeTynadol

Interventions

Naldebain DRUG

Oral Placebo A 650 mg + Naldebain 37.5 mg (0.5 mL oil solution) + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.

Also known as: Placebo A + Tween20 and PEG400

Naldebain

SafeTynadol DRUG

Oral SafeTynadol 650 mg + Placebo B (0.5 mL oil solution) +Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.

Also known as: Placebo B + Tween20 and PEG400

SafeTynadol

Naldebain + SafeTynadol DRUG

Oral Naldebain 37.5 mg (0.5 mL oil solution) + SafeTynadol 650 mg + Tween 20 and PEG 400 (1 capsule), multiple doses for 3 days. Dosing at 0（2 ± 2 hour after surgery）, 6 ± 2, 14 ± 2, 22 ± 2, 34 ± 2, 46 ± 2, 58 ± 2 and 70 ± 2 hours after the first dose.

Also known as: Tween20 and PEG400

Naldebain + SafeTynadol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≧ 20 years of age at Screening.
• Knee replacement patients.
• American Society of Anesthesiology Physical Class 1 and 2.
• Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

You may not qualify if:

• Body weight less than 50 kg.
• Subject is pregnant or breastfeeding. Women of childbearing potential have a positive urine pregnancy test at baseline.
• Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
• History of hypersensitivity or allergy to amide-type local anesthetics, opioid, acetaminophen, or any ingredient of the medications administered in this study.
• Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 %.
• Administration of an investigational drug within 5 elimination half-lives of such investigational drug prior to study drug administration.
• The investigator judged that any psychiatric disorder or psychological condition that may interfere with study assessments or compliance.
• History of abuse illicit medications, prescription medicines or alcohol within the past 2 years. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120 mL wine or 14 cans of 350 mL beer).
• Current painful physical condition other than knee pain.
• The investigator judged that the sensory nerve examination results were abnormal before the knee replacement in this trial.

Sponsors & Collaborators

• Sinew Pharma Inc.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Cheng-Fong Mr Chen, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: July 25, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TW (1)